These highlights do not include all the information needed to use GRALISE safely and effectively. See full prescribing information for GRALISE.
GRALISE® (gabapentin) tablets
Initial U.S. Approval: 1993
INDICATIONS AND USAGE
GRALISE is indicated for the management of Postherpetic Neuralgia (PHN).
Important Limitation: GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration (See Warnings and Precautions)
DOSAGE AND ADMINISTRATION
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GRALISE should be titrated to an 1800 mg dose taken orally, once-daily, with the evening meal. GRALISE tablets should be swallowed whole. Do not crush, split, or chew the tablets. (2.1)
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If GRALISE dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week or longer (at the discretion of the prescriber). (2.1)
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Renal impairment: Dose should be adjusted in patients with reduced renal function. GRALISE should not be used in patients with CrCl less than 30 or in patients on hemodialysis. (2.2)
DOSAGE FORMS AND STRENGTHS
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300 and 600 mg tablets (3)
CONTRAINDICATIONS
GRALISE is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. (4)
WARNINGS AND PRECAUTIONS
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GRALISE is not interchangeable with other gabapentin products
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Antiepileptic drugs, including gabapentin, the active ingredient in GRALISE, increase the risk of suicidal thoughts or behavior (5.1)
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Increased seizure frequ
